Peritoneal Dialysis, Continuous AmbulatoryCOMPASSNCT01887262
Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS
A study testing BCM-guided fluid management and Fluid management based on the clinical information alone in people with Peritoneal Dialysis, Continuous Ambulatory, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Peritoneal Dialysis, Continuous Ambulatory
- What is being tested?
- BCM-guided fluid management and Fluid management based on the clinical information alone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age bwten 20 and 75
- peritoneal dialysis > 4 weeks duration
- written consent
- daily urine output > 500 ml
Who cannot join
- subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants)
- pregnant women
- subjects who are expected to discontinue peritoneal dialysis with one year
- mixed dialysis modality (peritoneal + hemodialysis)
- hypoalbuminemic subjects (serum albumin < 3.3 g/dL)
- high blood pressure (> 160/100 mmHg despite antihypertensive medications)
- severe heart failure (NYHA FC III, or IV)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul, 110-744
About this study
Official title: Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial
Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.
- Being tested
- BCM-guided fluid management, Fluid management based on the clinical information alone
- Keywords
- fluid, edema
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCM-guided fluid managementDevice
Fluid management based on the clinical information aloneProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Incident peritoneal dialysis (PD) patients who are randomly allocated to BCM-guided fluid management will receive BCM measurement every two months over 1-year period. The BCM results will be notified to the physicians and the participating subjects. Based on the BCM results along with the clinical information such as blood pressure, edema and weight, the physicians will prescribe PD fluid and diuretics, targeting within 1L of overhydration status. They will prescribe dietary education to the patient, if necessary. Receives: Device: BCM-guided fluid management |
| Control | Active comparator | BCM will be measured at the beginning and end of the study, respectively. However, the BCM results will be blinded to the physicians and the control group. The physician will prescribe drugs, PD fluids, and dietary education to the patients based on the clinical information alone - such as blood pressure, edema and body weight. Receives: Procedure: Fluid management based on the clinical information alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
delta GFR
change of glomerular filtration rate from baseline to the 12th month
Measured: baseline and 12th month
Secondary outcomes (6)
GFR
glomerular filtration rate measured by urine collection, calculated by the mean of creatinine and urea clearance
Measured: at 12th month
time to anuria
time to the anuric state (urine volume < 100cc/d)
Measured: over 12 months
echocardiographic parameters
parameters obtained by echocardiographic measurements such as left ventracular mass index (LVMi), E/e' ratio, left vetricular end-diastolic volume (LVEDP), left ventracular ejection fraction (LVEF), left atrial volume indx (LAVI)
Measured: 12 months period
BP
systolic, diastolic blood pressure, pulse pressure
Measured: 12th month
cardiovascular event
fatal and nonfatal cardiovascular events - acute myocardial infarction (AMI), stroke, unstable angina, amputation, cardiovascular revascularization
Measured: over 12 months
BCM parameters
parameters measured by body composition monitoring (BCM), such as overhydration(OH), extracellular water (ECW), extracellular-to-intracellular water ratio (ECW/ICW)
Measured: baseline and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis, Continuous AmbulatoryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care Korea
- Responsible party
- Principal investigator, Kook-Hwan Oh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887262
- Sponsor's protocol ID
- COMPASS
- Acronym
- COMPASS
- Status last verified
- Apr 2018
- First submitted
- 24 Jun 2013
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Biesen W, Williams JD, Covic AC, Fan S, Claes K, Lichodziejewska-Niemierko M, Verger C, Steiger J, Schoder V, Wabel P, Gauly A, Himmele R; EuroBCM Study Group. Fluid status in peritoneal dialysis patients: the European Body Composition Monitoring (EuroBCM) study cohort. PLoS One. 2011 Feb 24;6(2):e17148. doi: 10.1371/journal.pone.0017148.
PubMed 21390320Baek SH, Oh KH, Kim S, Kim DK, Joo KW, Oh YK, Han BG, Chang JH, Chung W, Kim YS, Na KY. Control of fluid balance guided by body composition monitoring in patients on peritoneal dialysis (COMPASS): study protocol for a randomized controlled trial. Trials. 2014 Nov 6;15:432. doi: 10.1186/1745-6215-15-432.
PubMed 25376940
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial
- ClinicalTrials.gov ID
- NCT01887262
- Acronym / sponsor ID
- COMPASS / COMPASS
- Keywords
- fluid, edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Fresenius Medical Care Korea
- Study start
- Jul 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: BCM-guided fluid managementIncident peritoneal dialysis (PD) patients who are randomly allocated to BCM-guided fluid management will receive BCM measurement every two months over 1-year period. The BCM results will be notified to the physicians and the participating subjects. Based on the BCM results along with the clinical information such as blood pressure, edema and weight, the physicians will prescribe PD fluid and diuretics, targeting within 1L of overhydration status. They will prescribe dietary education to the patient, if necessary. |
| Control | Active comparator | Procedure: Fluid management based on the clinical information aloneBCM will be measured at the beginning and end of the study, respectively. However, the BCM results will be blinded to the physicians and the control group. The physician will prescribe drugs, PD fluids, and dietary education to the patients based on the clinical information alone - such as blood pressure, edema and body weight. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age bwten 20 and 75
- peritoneal dialysis > 4 weeks duration
- written consent
- daily urine output > 500 ml
Key exclusion criteria (7 listed)
- subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants)
- pregnant women
- subjects who are expected to discontinue peritoneal dialysis with one year
- mixed dialysis modality (peritoneal + hemodialysis)
- hypoalbuminemic subjects (serum albumin < 3.3 g/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCM-guided fluid management | Device | Intervention |
| Fluid management based on the clinical information alone | Procedure or surgery | Control |
Primary outcome
delta GFR
Time frame: baseline and 12th month
change of glomerular filtration rate from baseline to the 12th month
6 secondary outcomes
GFR
Time frame: at 12th month
time to anuria
Time frame: over 12 months
echocardiographic parameters
Time frame: 12 months period
BP
Time frame: 12th month
cardiovascular event
Time frame: over 12 months
BCM parameters
Time frame: baseline and 12th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 21390320Van Biesen W, Williams JD, Covic AC, Fan S, Claes K, Lichodziejewska-Niemierko M, Verger C, Steiger J, Schoder V, Wabel P, Gauly A, Himmele R; EuroBCM Study Group. Fluid status in peritoneal dialysis patients: the European Body Composition Monitoring (EuroBCM) study cohort. PLoS One. 2011 Feb 24;6(2):e17148. doi: 10.1371/journal.pone.0017148.
- Derived from this study: PubMed 25376940Baek SH, Oh KH, Kim S, Kim DK, Joo KW, Oh YK, Han BG, Chang JH, Chung W, Kim YS, Na KY. Control of fluid balance guided by body composition monitoring in patients on peritoneal dialysis (COMPASS): study protocol for a randomized controlled trial. Trials. 2014 Nov 6;15:432. doi: 10.1186/1745-6215-15-432.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCM-guided fluid management and Fluid management based on the clinical information alone in people with Peritoneal Dialysis, Continuous Ambulatory, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delta GFR (time frame: baseline and 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01887262, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.